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Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors (GIG-T)

Primary Purpose

Germ Cell Tumor

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Thromboprophylaxis
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Germ Cell Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the International Germ Cell Cancer Collaborative Group) Older than 18 years Suitable for first-line cisplatin-based chemotherapy No prior systemic cytotoxic therapy Signed informed consent Additional criteria for patients who will be randomized (Venous Thromboembolic Event (VTE) high-risk patients): Lactate dehydrogenase higher than 1 Upper Normal Level and/or Body Surface Area higher than 1.9 and/or longer than 5 cm long axis retroperitoneal lymph nodes Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: Brain metastasis History of VTE Concomitant use of anticoagulants or antiaggregants Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to closure) within 4 weeks or planned during the study treatment period Severe uncontrolled high blood pressure (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) Low baseline platelet count (< 100 X 10^9 /L) or history of heparin-induced thrombocytopenia Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities Extensive metastatic disease at high risk of bleeding, e.g. prevalent choriocarcinoma Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Sites / Locations

  • ICO Paul PapinRecruiting
  • CH de la Côte Basque
  • CHU de Clermont-FerrandRecruiting
  • Centre Oscar Lambret
  • CHU de LimogesRecruiting
  • Centre Léon Bérard
  • Centre Antoine Lacassagne
  • CHU de PoitiersRecruiting
  • Clinique La Croix du Sud
  • HIA Bégin
  • ICANS
  • CHU Bretonneau
  • Institut de Cancérologie de Lorraine
  • Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Experimental for high-risk patients

Control for high-risk patients

Low-risk patients

Arm Description

Thromboprophylaxis in addition of the standard chemotherapy

No thromboprophylaxis in addition of the standard chemotherapy

No thromboprophylaxis in addition of the standard chemotherapy

Outcomes

Primary Outcome Measures

Proportion of patients undergoing a thromboembolic event
(composite end point: symptomatic or asymptomatic (incidental finding) venous thrombosis or pulmonary embolism or unexplained death)

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
October 18, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05874063
Brief Title
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Acronym
GIG-T
Official Title
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2023 (Actual)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to assess the efficacy of thromboprophylaxis in preventing venous thromboembolic events (VTE) in good and intermediate prognosis patients with metastatic germ cell cancer (GCT) undergoing first-line cisplatin-based chemotherapy with risk factors for developing a thromboembolic event . The high-risk patients will be randomized between two treatments arm (receiving a thromboprophylaxis in the experimental arm, or no thromboprophylaxis in the control arm). The low-risk patients will be observed without any thromboprophylaxis. Patients will participate in the study for 14-17 weeks depending on the planned number of cycles of chemotherapy. Researchers will compare an experimental arm with thromboprophylaxis and a control arm without thromboprophylaxis to detect an absolute decrease of 12% of the proportion of patients having experienced a VTE, from 21% (high risk patients, control arm) to 9% (high risk patients, experimental arm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
387 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental for high-risk patients
Arm Type
Experimental
Arm Description
Thromboprophylaxis in addition of the standard chemotherapy
Arm Title
Control for high-risk patients
Arm Type
No Intervention
Arm Description
No thromboprophylaxis in addition of the standard chemotherapy
Arm Title
Low-risk patients
Arm Type
No Intervention
Arm Description
No thromboprophylaxis in addition of the standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
Thromboprophylaxis
Intervention Description
Thromboprophylaxis in addition of the standard chemotherapy
Primary Outcome Measure Information:
Title
Proportion of patients undergoing a thromboembolic event
Description
(composite end point: symptomatic or asymptomatic (incidental finding) venous thrombosis or pulmonary embolism or unexplained death)
Time Frame
from randomization up to 6 weeks after D1 of the last cycle of chemotherapy or up to the residual masses surgery, whichever occurs first.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the International Germ Cell Cancer Collaborative Group) Older than 18 years Suitable for first-line cisplatin-based chemotherapy No prior systemic cytotoxic therapy Signed informed consent Additional criteria for patients who will be randomized (Venous Thromboembolic Event (VTE) high-risk patients): Lactate dehydrogenase higher than 1 Upper Normal Level and/or Body Surface Area higher than 1.9 and/or longer than 5 cm long axis retroperitoneal lymph nodes Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: Brain metastasis History of VTE Concomitant use of anticoagulants or antiaggregants Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to closure) within 4 weeks or planned during the study treatment period Severe uncontrolled high blood pressure (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) Low baseline platelet count (< 100 X 10^9 /L) or history of heparin-induced thrombocytopenia Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities Extensive metastatic disease at high risk of bleeding, e.g. prevalent choriocarcinoma Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibault RAOULT, MSc
Phone
+33 (0)1 42 11 42 11
Email
thibault.raoult@gustaveroussy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Fizazi, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO Paul Papin
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOUGHALEM Elouen, MD
Facility Name
CH de la Côte Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCOIS Louis, MD
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BAILLY Sébastien, MD
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARBONNELLE Guillaume, MD
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DARBAS Tiffany, MD
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FLECHON Aude, MD
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DUCOULOMBIER Agnes, MD
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMAMBUX Sheik, MD
Facility Name
Clinique La Croix du Sud
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RICCI Francesco, MD
Facility Name
HIA Bégin
City
Saint-Mandé
ZIP/Postal Code
94160
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HELISSEY Carole, MD
Facility Name
ICANS
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIERARD Laure, MD
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CANCEL Mathilde, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre les nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GEOFFROIS Lionnel, MD
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Fizazi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

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